A Prospective, Randomized, Multicenter Clinical Trial of Non-slip Balloon Catheter in Patients With Coronary Artery Stenosis

Shanghai MicroPort Rhythm MedTech Co., Ltd.1 site in 1 country200 target enrollmentJanuary 3, 2023

ConditionsCoronary Artery Stenosis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Coronary Artery Stenosis
Sponsor: Shanghai MicroPort Rhythm MedTech Co., Ltd.
Enrollment: 200
Locations: 1
Primary Endpoint: Acute Lumen Gain
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, multicenter, randomized controlled clinical investigation aiming to evaluate the safety and effectiveness of non-slip balloon catheter for the treatment of patients with coronary artery stenosis.

Detailed Description

This trial is a prospective, multicenter, randomized controlled clinical trial. 200 subjects are expected to be recruited in 7 research centers in China and randomly divided into two groups according to the ratio of test group: control group = 1:1. The primary endpoint is the acute lumen gain. All subjects receive clinical follow-up during hospitalization and 30 days after surgery.

Registry

clinicaltrials.gov

Start Date

January 3, 2023

End Date

October 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai MicroPort Rhythm MedTech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects aged≥18 years.
•Subjects with silent myocardial ischemia, symptomatic angina pectoris, or old myocardial infarction.
•Subjects who can undergo percutaneous coronary intervention (PCI).
•Subjects who are able to understand the purpose of the trial, participate voluntarily and indicate by signing the informed consent form that they recognize the risks and benefits described in the informed consent document and are willing to undergo clinical follow-up.
•Angiography Inclusion Criteria:
•For subjects with single or double lesions, revascularization is required for up to two lesions; at most one non-target lesion can be treated in the same period, and the target lesion can be treated only after the treatment of non-target lesion meets the angiography success criteria and there is no complication. Target and non-target lesions must be located in different major epicardial vessels.
•Target lesion meets criteria for revascularization:
•≥ 70% and \< 100% diameter stenosis; or
•≥ 50% and \< 70% diameter stenosis with clinical evidence of ischemia
•Target lesion vessel diameter is between 2.0 mm and 4.0 mm (inclusive), target lesion length ≤ 30 mm.

Exclusion Criteria

•Subjects who present with AMI recently (within 7 days).
•Subjects who plan to undergo rotational atherectomy, laser coronary atherectomy, cutting balloon during target lesion pretreatment.
•Subjects who are scheduled for PCI or CABG within 1 month of the index procedure.
•Subjects with history of ischemic stroke or transient ischemic attack within 3 months.
•Subjects with bleeding tendency, active gastrointestinal ulcer, history of cerebral hemorrhage or subarachnoid hemorrhage, contraindications to antiplatelet agents and anticoagulant therapy, and inability to receive antithrombotic therapy within 6 months.
•Subjects who are scheduled for additional surgical procedures requiring discontinuation of aspirin, clopidogrel within 6 months of the baseline procedure.
•Subjects with severe heart failure (NYHA III and above) or left ventricular ejection fraction(LVEF) \< 35% (ultrasound or left ventriculography) and/or hemodynamic instability.
•Subjects with unstable arrhythmias, such as high-risk premature ventricular contractions, ventricular tachycardia, high-grade atrioventricular block.
•Subjects who are unable to receive antiplatelet therapy.
•Subjects with hypersensitivity to aspirin, heparin, contrast agent, cobalt-based alloys (including metal elements such as cobalt, chromium, nickel, and tungsten), and polytetrafluoroethylene.

Outcomes

Primary Outcomes

Acute Lumen Gain

Time Frame: Baseline procedure

Acute lumen gain is defined as the difference in the minimum lumen diameter of the target lesion before and after dilatation with the study balloon catheter (Microport or NSE Coronary Dilatation Catheter) as measured by QCA. (Acute lumen gain = minimum lumen diameter measured after dilatation with the study balloon catheter - minimum lumen diameter measured before dilatation with the study balloon catheter, AG=MLD post - MLD pre)